About this trial
The goal of this clinical trial is to investigate if ultrasound contrast agents can be used to estimate filling pressures inside the heart in patients with suspected heart disease. The main questions it aims to answer are:
* Is there a strong correlation between the contrast signal and filling pressures inside the heart? * What is the calibration approach to convert the contrast signal from dB to a measure of pressure in mmHg?
Researchers will compare the contrast signal with reference pressures measured using a catheter to see if it can be used to quantify filling pressures inside the heart.
Participants will:
* Be exposed to a small amount of additional ionising radiation to guide a catheter in position inside the heart for reference pressures * Receive an ultrasound contrast agent at the clinically recommended dose and in line with clinical guidelines, via an intravenous line in their arm * Undergo contrast echocardiography - ultrasound scan of their heart with contrast * Undergo standard echocardiography - ultrasound scan of their heart without contrast
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to give informed consent to participate in the study
Patients who require a cardiac catheterisation procedure as part of their standard medical care
Good acoustic windows for echocardiography when lying flat on their back
Disqualifiers
Known previous allergy to SonoVue, used in ultrasound contrast scans
Known allergy to any of the components of SonoVue microbubbles, for example, sulphur hexafluoride or polyethylene glycol (PEG), also known as macrogol, which is in bowel preparations used during colonoscopy and certain laxatives
A hole in their heart that lets blood flow from the right side to the left, skipping the lungs
Very high blood pressure in the arteries of the lungs (severe pulmonary hypertension)
Trial design
Single group
Treatments tested in this trial
Contrast Echocardiography
Other interventionSimultaneous contrast echocardiography and cardiac catheterisation for intracardiac pressures in the cardiac catheterisation laboratory
Treatment groups
Trial outcomes
Primary outcomes
Correlation between the signal of the ultrasound contrast agent SonoVue and intracardiac pressure measured using a catheter
The ultrasound signal of SonoVue at the subharmonic frequency will be compared with left ventricular filling pressures measured using a high-fidelity catheter.
Secondary outcomes
Intracardiac pressure estimated from the ultrasound signal of SonoVue, converted from dB to mmHg using an ultrasound-based calibration approach
The signal of ultrasound contrast agents has to be calibrated to convert it from dB to mmHg for pressure. Ultrasound-based approaches involving standard echocardiography and high frame rate contrast echocardiography will be investigated as potential calibration approaches in this study.
Sponsors and contacts
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King's College London
Lead sponsor
King's College Hospital NHS Trust
Collaborator